MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-23 for WALKAWAY 96 PLUS B1018-284 manufactured by Siemens Healthcare Diagnostics.
[5324403]
It was reported that the hinge spring was ejected from the panel access door of the walkaway plus instrument. The operator was not wearing an eye protection however no injury or adverse event occurred.
Patient Sequence No: 1, Text Type: D, B5
[12898261]
(b)(4). The reported walkaway plus system was part fca msi 14-01 (fda z-1990-2014). Modification of the door hinges was performed on (b)(6) 2014. The system was fully functional after the modification was performed. On (b)(6) 2014 the customer reported they were having issues with the access door. A service engineer was dispatched; however, he was not able to align the door and ordered a new panel access door assembly; installed on (b)(6) 2014 and the system was fully functional. The instrument's door hinges operated without incident until (b)(6) 2014. Upon event describe in block 5,a service engineer was dispatched and the door hinge was modified. The instrument is functioning properly based upon completion of the specific service leak.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00003 |
| MDR Report Key | 4460617 |
| Report Source | 05 |
| Date Received | 2015-01-23 |
| Date of Report | 2014-12-31 |
| Date of Event | 2014-12-31 |
| Date Mfgr Received | 2014-12-31 |
| Date Added to Maude | 2015-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1990-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 96 PLUS |
| Generic Name | WALKAWAY 96 PLUS |
| Product Code | LRG |
| Date Received | 2015-01-23 |
| Catalog Number | B1018-284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-23 |